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Background Main aim: To evaluate the retention rate of ustekinumab compared to vedolizumab in Crohn’s disease patients who failed anti-TNF therapy in clinical practice. Secondary aims: To compare the short-term and long-term effectiveness, and the safety of both treatments. Methods Crohn’s disease patients who had received either vedolizumab or ustekinumab after failure or intolerance to anti-TNF agents from ENEIDA registry were included. ENEIDA is a prospectively maintained database promoted by GETECCU. A total of 755 patients from 30 centres were included at time of data extraction. Clinical activity was classified based on Harvey-Bradshaw index both at short (during induction) and in the long-term. Kaplan-Meier curves, Cox regression models, inverse probability weighting and propensity matching score analyses were performed to compare both drugs and to identify predictive factors of treatment effectiveness and durability. Results 755 patients were included (195 in the vedolizumab cohort and 560 in the ustekinumab cohort). After a median of 20 months (IQR 7.4–30) of follow-up, the survival rate for ustekinumab therapy was higher than vedolizumab (Figure 1). The propensity matching score verified the differences between both therapies. The short-term proportion of patients on clinical remission, steroid-free remission and clinical response was also superior in the ustekinumab cohort (Figure 2). In the long-term, significant differences were observed 2 years after the beginning of the treatments, although no differences in clinical response and remission rates were detected in patients who achieved clinical response at week 16 between both cohorts. Vedolizumab was discontinued in 142 patients and ustekinumab in 185, mainly due to primary non-response (52% in the vedolizumab and 58% in the ustekinumab cohort) and loss of response (34% and 25%, respectively) despite the fact that 35% of the patients required intensification. The predictive factors associated to the discontinuation of the therapy are described in table 1. Adverse events were observed, overall, in 12% of the patients, without differences between both groups (Table 2). Following the discontinuation of the treatment with vedolizumab/ustekinumab, other biologic agents were prescribed in 56% of the patients, and 27% underwent surgery. Conclusion In clinical practice, a relatively high proportion of Crohn’s disease patients who received ustekinumab or vedolizumab for anti-TNF failure, maintained these drugs in the medium-long term, although ustekinumab retention rate was higher in comparison with vedolizumab.

Background Main aim: To assess the retention rate of tofacitinib treatment in patients with ulcerative colitis (UC). Secondary aims: To assess the short-term effectiveness and the durability of response; to evaluate the evolution of extraintestinal manifestations (EIMs) and immunomediated inflammatory diseases (IMIDs); to assess the tolerability of tofacitinib in clinical practice. Methods Retrospective, multicenter study. UC patients who had received the first tofacitinib dose at least, 8 weeks before the start date of recruitment. Patients were followed-up from the first tofacitinib dose to treatment discontinuation or last visit, whichever came first. Only patients with active disease [Partial Mayo Score (PMS)>2] were considered in the short-term effectiveness analysis. Clinical response was based on the PMS. Variables associated with short-term remission were identified by logistic regression analysis. Kaplan-Meier curves and Cox-regression analysis were used to evaluate the long-term effectiveness and durability of tofacitinib treatment. Results 335 patients have been included so far (recruitment still ongoing) (Table 1). A total of, 70 patients (21%) would have met the criteria for entering A3921133 trial. A total of, 155 patients interrupted tofacitinib during follow-up (Figure 1a), mainly due to primary non-response (46%) and loss of response (25%); predictive factors of tofacitinib discontinuation are shown in figure 1b. Short-term effectiveness and predictive factors of remission are shown on figure 2;, 16% of non-responders and, 35% with partial response at week, 4 reached remission at week, 8, and, 19% of non-responders and, 37% of partial responders at week, 8 reached remission at week, 16. Of, 151 patients in remission at week, 8, 68 (45%) lost response (Figure 3); tofacitinib dose was increased in, 27%, and, 71% of them reached remission again. Obvious blood with stool most of the time or blood alone passed at baseline was the only variable associated with losing response over time. There were, 86 adverse events related to tofacitinib treatment (Table 2). Fifty-seven patients (17%) had EIMs or IMIDs non-active at tofacitinib start; only, 2 out of, 12 patients with peripheral arthropathy worsened., 53 patients (16%) had active EIMs or IMIDs at the start of tofacitinib and some of them improved. A total of, 17 EIMs or IMIDs occurred after starting tofacitinib but only, 1 (vasculitis) caused tofacitinib withdrawal. Conclusion Tofacitinib is effective in inducing remission even in highly refractory UC patients. A relevant proportion of patients discontinue the treatment, mainly during the first months due to primary failure. The safety profile is similar to that previously reported for tofacitinib

Background The management of inflammatory bowel disease (IBD) has substantially changed in the last decades, both in relation to medical and surgical treatments. Aims Principal: To know the rate of surgery in a newly diagnosed IBD cohort within the first year after diagnosis. Secondary: To describe the type of surgeries and indications in this cohort, and to identify predictive factors for surgery (focused on intestinal resection) in these patients. Methods Prospective, population-based nationwide registry. Adult patients diagnosed with IBD -Crohn’s disease (CD) and ulcerative colitis (UC)- during 2017 in Spain were included and were followed-up for 1 year. Kaplan-Meier curves were used to calculate the rate of surgery. In patients with intestinal resections, only medical treatments before surgery were considered. Predictive factors for surgery were identified by Cox-regression analysis. Results 3,454 patients (1,647 CD and 1,807 UC) were included (table 1). The incidence rate for surgery was significantly higher among CD patients (figure 1). A total of 197 patients (6%) underwent surgery within the first 12 months: 126 (64%) intestinal resections, and 71 (36%) perianal surgeries. Fifty-seven percent of intestinal resections were urgent, and 43% elective. The main indications for intestinal resections were: intestinal obstruction in 37%, abscess/fistula in 27%, perforation/acute abdomen in 25%, and refractoriness to medical treatment in 18% of cases. A total of 174 CD patients (10.6%) underwent surgery ¾61% intestinal resections and 39% perianal. Twenty-three UC patients (1.3%) were operated on; the number of surgeries in UC was too low to identify predictive factors. In CD patients, to have been treated with thiopurines [Hazard ratio (HR)=0.2, 95% confidence interval (CI)=0.1–0.3) was associated with lower likelihood of intestinal resection. Disease behaviour at diagnosis [stricturing vs. inflammatory (HR=6.5, 95%CI=4–10) and fistulising vs. inflammatory (HR=13, 95%CI=9–21)] was associated with the risk of intestinal resection. Biologic treatment was not associated with the likelihood of intestinal resection (figure 2). Conclusion Six percent of IBD patients undergo surgery within the first year of diagnosis, being higher in CD (11%) than in UC (1.3%). Sixty percent of intestinal resections are urgent procedures. The risk of surgery is increased in CD patients with fistulising and stricturing behaviour. Thiopurine, but not biologic treatment, is associated with lower risk of surgery.

Background Quality of care (QoC) is a highly important topic in inflammatory bowel disease (IBD). We recently elaborated a decalogue of QoC indicators (IQCARO-QoC) developed by IBD patients. The aim of the present study was to assess the factors associated with patients’ evaluation of QoC in Spain using the IQCARO-QoC Decalogue recently developed by IBD patients. Methods A survey including patients’ socio-demographic and clinical characteristics, and the IQCARO-QoC Decalogue, was completed by IBD patients. We described patients’ assessment of QoC across Spanish patients. A univariable and multivariable analysis was performed to explore the associations between patients’ characteristics and QoC. Results Questionnaires from 788 participant patients were analysed. Participants’ mean age was 43.4 years, 63% were females and 58% had Crohn’s disease. The mean QoC score was 8.1 (± 2.4 SD) points out of a maximum of 10. Items with the lowest score were related to the provision of information and the implication of the medical team throughout the entire patient care. Factors associated with better QoC scores included: being employed better disease control, fewer numbers of unscheduled visits, and being followed by a gastroenterologist specialized in IBD. Conclusions Spanish patients’ reported QoC seems to be globally good although there is room for improvement, especially in providing adequate information to patients. Care provided by specialized IBD gastroenterologists seems to be related with higher QoC scores.

Background The prevalence of hepatitis C virus infection (HCV) in patients with inflammatory bowel disease (IBD) ranges from 1–6%. Direct-acting antivirals (DAAs), with cure rates >90%, represent a radical change from interferon-based therapies. The ECCO guidelines (Kucharzik JCC 2021) warns about the risk of IBD reactivation due to the effect of DAAs, but HCV management in this situation is uncertain given the lack of evidence. AIMS: To evaluate: 1) Effectiveness and safety of DAAs in IBD; 2) Interaction of DAAs with IBD drugs, particularly immunosuppressants and/or biologics. Methods Multicenter retrospective study of patients with IBD and HCV treated with DAAs identified on the ENEIDA registry (January 2011-February 2021). Variables evaluated: age, gender, location, extent, phenotype and activity of IBD, treatments, anti-HCV and viral load, DAA treatment and duration, fibrosis and hepatic decompensations, adverse effects (AE) and interactions. Results We included 79 patients with IBD and HCV treated with DAAs (47 sofosbuvir, 28 ledipasvir, 7 daclatasvir, 8 velpatasvir, 1 simeprevir, 16 paritaprevir+ritonavir+ombitasvir, 14 dasabuvir, 3 grazoprevir+elbasvir, 13 glecaprevir+pibrentasvir). Clinical and demographic characteristics: mean age (years) 54+/-12.66SD; 62% male, 77.2% genotype 1, 32.6% advanced fibrosis (none Child B-C). A 78.5% (n=62) received IBD treatment (39 salicylates, 20 azathioprine, 1 methotrexate, 4 corticosteroids, 10 antiTNF, 2 vedolizumab, 2 ustekinumab, 1 apheresis). A 17.7% (n=14) had active IBD (64.3% remained unchanged, 21.4% improved and 14.3% worsened) and 82.3% (n=65) were inactive at the onset of ADD. Of these, 9.2% (n=6) developed mild-moderate activity (4 mild and 2 moderate). In 85% (n=67) no treatment changes were made, in 9% (n=7) it was intensified and in 6% (n=5) it was de-intensified. Adherence to DAAs and sustained virologic response was obtained in 96.2% (n=76). A total of 7 (8.9%) AE were notified, of which 5 were possibly/probably related to DAAs (100% mild) and 2 were unrelated (1 azathioprine withdrawal due to pancytopenia). The AE were unrelated with the presence of inflammatory activity, type of IBD, liver fibrosis, use of immunosuppressants, biologics, or with any DAA regimen. Conclusion This is the first reported series of IBD patients infected with HCV and treated with DAAs, we showed that DAA are effective and safe. They do not trigger IBD flare-ups, nor have more AE than in patients without IBD. Moreover, they do not have clinically significant pharmacological interactions with immunosuppressants and/or biologics. Thus, the eradication of HCV with DAA in IBD patients must be the same of the HCV infected patients without IBD, based on EASL recommendations.

Background Ulcerative proctitis may have a mild and less aggressive course, although evidence is scarce because these patients are excluded from participation in randomized controlled clinical trials. The aim is to identify clinical characteristics and complications associated with ulcerative proctitis refractory to conventional therapy. Methods Patients included in the prospectively maintained ENEIDA registry from GETECCU with ulcerative proctitis were included. Socio-demographic data were evaluated. We defined ulcerative proctitis based on ECCO guidelines and immunosuppression as the use of immunomodulators and/or biologics. Logistic regression was used to identify the independent factors associated with immunosuppressive therapy among the different socio-demographic data. Results From a total of 34.716 patients with ulcerative colitis, 6281 (18%) patients with ulcerative proctitis were identified. Mean age was 53 ±15 years and mean duration of illness was 12 ± 9 years. Surgery was necessary only in 2% of patients, 31 (0.5%) panprotocolectomy or subtotal colectomy. The clinical characteristics of the patients with and without immunosupressive therapy are summarized at table 1. A total of 3691 patients received oral 5-ASA (58.8%) and 4652 (74.1%) topic 5ASA. 636 (10.1%) were refractory to 5-ASA and corticosteroids, necessitating immunosuppression: 459 patients with azathioprine (7%), 28 with 6-mercaptopurine (0.4%), 49 with methothrexate (0.8%), 191 with infliximab (9%), 125 with adalimumab (2%), 50 with golimumab (0.8%), 57 with vedolizumab (0.9%), 6 with ustekinumab (0.1%) and 3 with tofacitinib (0.0). 316 (5%) patients needed one biologic therapy, 95 (1.5%) needed 2 biologics and 40 (0.6%) at least three different biologics. Longer duration of illness and use of corticosteroids were associated with higher risk of immunosuppression. Conclusion Good clinical outcomes were recorded in ulcerative proctitis, with only 10% of patients treated with immunosuppression therapy. The risk factors of immunosuppression were longer duration of illness and use of corticosteroids.

Background Spanish inflammatory bowel disease (IBD) group (GETECCU) mission is to promote healthcare, teaching and research of excellence. Our vision is to establish standards of quality of care and generate a mark of excellence and reliability for IBD patients and the different agents involved in all its processes. The aim of this study was evaluate the impact of a program for certification of IBD units (CUE program). Methods Identification of quality indicator for certification of IBD Units was based on CUE Delphy methodology that finally selected 53 quality indicators (12 structure, 37 process and 4 results), which were subjected to a normalisation process (Calvet X et al. JCC 2014; 8: 240–51). This process consisted of face-to-face protocoled meetings with a committee of experts that proceeded to defined/justified the use of each indicator considering objectiveness and the measure of compliance. Applications for certification in the program are made voluntarily through the GETECCU secretariat. From GETECCU, the candidate units are counselled through a consulting round before an audit drill and finally, the formal audit carried out by an independent certifying agency. This audit consists of the review of all selected indicators and includes a review of 40 random medical records. If 80–90% compliance is achieved, the qualification of ‘advanced’ is obtained and the unit is re-certified in 2 years. If it exceeds 90%, the rating is ‘excellence’ and the unit has to be re-certified in 3 years. An anonymous survey was conducted among certified units to assess satisfaction with the program Results The CUE program started in 2017. As of November 2019, there are 53 IBD units adhered to the certification nationwide program, of which 42 have already been audited and 40 certified. Twenty-three units achieved the qualification of excellence (56%), 17 achieved an advanced qualification and 5% had not passed the certification. The remaining 11 are currently in the process of being audited. After an IBD Unit achieve the certification an act of official delivery is carried out with the presence of patient associations, public care authorities and the board of GETECCU. Results are published in the State Official Gazette. Survey main results were the average perceived improvement, averaged as 8.5, out of 10. The most important aspect of improvement is data recording followed by health and patient satisfaction results Conclusion The establishment of quality standards certification programmes in multidisciplinary units improves the quality of care offered to IBD patients. The acceptance among the health community for adherence to these projects is very high despite being voluntary. The support of patient associations and managers is essential to value these types of projects

Background There are limited data of long-term ustekinumab administered according to the doses recommended in the UNITI studies. The objective of this study was to assess the real-world, long-term effectiveness of ustekinumab in refractory Crohn’s disease (CD) (LONG-CROHNUSK Study). Methods Multicentre study of CD patients starting ustekinumab at the recommended dose based on weight ~6 mg/kg IV week 0, 90 mg SC week 8 and maintenance 90 mg SC every 8 or 12 weeks and with 1 year of follow-up. Values for Harvey-Bradshaw Index (HBI), endoscopic activity, C reactive protein (CRP) and faecal calprotectin (FC) were recorded at baseline and at weeks 26 and 52. Demographic and clinical data, previous treatments, adverse events (AEs), surgeries and hospitalisations were documented. Potential predictors of clinical and endoscopic remission were examined. Results Four hundred and seven patients were analysed (Table 1). For the maintenance dose, ustekinumab 90 mg was administered SC every 12, 8 and 4 weeks in 56 (14%), 318 (84.5%) and 7 (1.5%) patients, respectively. An interval reduction was applied for 118 patients (29%). Before 52 weeks, treatment discontinuation occurred in 71 patients (17%). At baseline, 295 (72%) had an HBI >4 points. Of these, 169 (57%) and 190 (64%) achieved clinical remission at weeks 26 and 52, respectively. FC levels returned to normal ( Conclusion This is the first study to show the real-world long-term effectiveness, endoscopic improvement and safety of ustekinumab administered according to the recommended induction regimen in a cohort of highly refractory CD patients.

Background A less aggressive phenotype of Crohn’s disease (CD) has been reported in patients with elderly onset CD. Despite this, similar surgical rates among younger and older CD patients have been reported. However, scarce data are available about the risk of postoperative recurrence (POR) regarding the age, and no data are available about the use of immunosuppressants and biological agents for prevention of POR in elderly patients. Our aim was to evaluate the management of CD in the postoperative setting and the rate of surgical POR in CD patients according to the age at surgery. Methods Cohort study including all adult CD patients in the ENEIDA registry (a prospectively-maintained database of the Spanish Working Group in IBD –GETECCU-) who underwent a first intestinal resection with ileo-colonic anastomosis. Patients were grouped regarding their age at the moment of the first surgery: over 60 years (elderly) and between 18 and 60 years of age (controls). Preventive treatment for POR, surgical POR (need for a further intestinal resection) and postoperative morbidity were compared between both groups. Results Out of the 69,740 IBD patients included in the ENEIDA database, 3,982 had a first intestinal resection for Crohn’s disease with an ileo-colonic anastomosis between 2005 and 2020. Of them, 535 were elderly and 3,454 controls. Time from IBD diagnosis to surgery was significantly longer in the elderly (114±128 vs. 93±97 months; p Conclusion The elderly patients show similar rates of surgical POR as compared to younger patients. Given the high risk of thiopurine and anti-TNF-related adverse events, elderly patients with inflammatory pattern would benefit from preventive therapy with safer biologicals.

Background Inflammatory Bowel Disease (IBD) can be a cause of disability. To date, the scores that evaluate disability in IBD patient use mainly subjective criteria. The aim of this study was to develop and validate an index of disability in IBD based on objective, measurable criteria. Methods IBD patients from the Catalan and Spanish Crohn and Colitis Associations volunteered to fulfill an online self-administered survey. Demographic, clinical, and therapeutic variables were collected. They also informed on whether they have a recognized disability and whether they receive a work disability pension. Patients were divided into a training and validation set. In the training set, different multivariate analyses were carried out to evaluate objective variables related to having a recognized work disability, a general disability or a moderate or severe degree of disability. The score was elaborated with the statistically or clinically significant variables present in the multivariate analyses. The ROC curves for predicting general and work disability were calculated. Results 981 valid surveys were included. Sixty six percent of the patients were women, mean age was 40.9 years and 59.3% had Crohn’s disease. Of these patients, 85 (9.1%) had a recognized work disability and 429 (45.9%) had a degree of recognized general disability. The results of the multivariate analyses are shown in table 1. Eight variables were selected to develop the inflammatory bowel disease objective work disability index (ODIBD) (table 2). Each variable was scored one point to calculate the final index. The AUROC of the index in the training group was 0.76 for work disability and 0.71 for general disability. The AUROC of the index in the validation group was 0.83 for work disability and 0.67 for general disability (fig1). Conclusion The ODIBD may be useful score to objectively assess of work disability in patients with IBD.

Background The prevalence of penetrating disease in Crohn’s disease (CD) increases progressively over time, and evidence on the medical treatment of this complication is limited. The aim of this study was to evaluate the efficacy of biologic agents in CD complicated with internal fistulising disease. Methods A retrospective analysis of all adult patients from the ENEIDA registry (>68,000 patients) with CD who received at least one biologic agent -anti-TNF, ustekinumab or vedolizumab- for penetrating disease was performed. Exclusion criteria comprised treatment for perianal disease, enterocutaneous, anastomotic or periostomal fistula tracts. The main outcomes were fistula-related surgery and fistula closure on cross-sectional imaging. Preestablished secondary outcomes included the rate of abdominal abscess, the need for percutaneous drainage, the changes in the number of fistula tracts, fistula closure rates, and the safety profile.The baseline characteristics were analyzed by means of descriptive statistics and were compared by non-parametric tests. Predictive factors associated with surgery and fistula closure were evaluated by a multivariable logistic regression and survival analyses. Results A total of 710 patients (median age 38 years [IQR, 28-48], 59% male, 55% L3) receiving 791 biologic treatments were included at 53 sites (701 anti-TNF, 71 ustekinumab, and 19 vedolizumab). Patients had a median of 1 (range 1-5) fistula tracts, 49% of them entero-enteric followed by entero-colic (28%). After a median follow-up of 59 months (IQR, 27-105), 244 patients (31%) required surgery due to internal fistulising complications after 8.5 months (IQR, 3-24). Patients with ileocolonic disease (OR 1.99 [1.22-3.23]), entero-urinary fistulas (OR 2.35 [1.17-4.73]), or with a stricture distal to the fistula (OR 2.1 [1.31-3.36]) showed a higher risk of surgery, with no differences between biologic drugs (Figure 1). Combination therapy reduced the risk of surgery (HR 0.58 [0.37-0.90]). Fistula closure was observed in 24% of patients after a median of 15 months (IQR, 7.5-27). Patients with a lower number of fistula tracts showed a higher probability of closure (OR 1.72 [1.09-2.7]). Conclusion A high proportion of patients with internal fistulizing CD benefit from biologic treatment after a median of 5 years. During this follow-up, around two thirds of patients are free of surgery and one in every four patients achieves fistula closure.

Background Crohn’s disease (CD) can develop fistulizing complications at any time during the disease course. Enterocutaneous fistulas (ECF) are disabling lesions with a significant impact on quality of life. The aim of this study was to describe the characteristics and natural history of ECF complicating CD, and to analyze its medical and/or surgical management. Methods A retrospective analysis of all adult patients with fistulizing CD with at least one episode of ECF from the ENEIDA registry (over 68,000 patients) was performed. ECF were defined as a communication between the gastrointestinal tract and the skin producing leakage of luminal contents. Additional data describing the ECF and its medical or surgical management were gathered. The main endpoint was any ECF-related surgical intervention. Fistula closure was defined as the absence of drainage, with no new abscess or surgery for at least 6 months. A comparison of the characteristics and outcomes after the availability of biologic agents (Jan/2000) was also performed. The baseline characteristics were analyzed by means of descriptive statistics and were compared by non-parametric tests. Factors associated with surgery were further evaluated in a binary multivariable regression and survival analysis. Results A total of 301 ECF in 286 patients from 46 hospitals diagnosed between Jan/1970-Sept/2020 were included (median age 34 years (IQR, 27–46); 59% male; 67% L3). ECF had a median of 1 external opening (range 1–10), 59% with concomitant internal fistulas, and usually involved the ileum (67%) or colon (23%). After 146 months (IQR, 69–233) of follow-up, 37% received thiopurines, 40% anti-TNF, 6% ustekinumab and 2% vedolizumab. Surgery was performed in 208 patients (69%) after a median of 4 months (IQR, 1.4–12). Fistula closure was achieved in 253 patients (84%) after 30 months (IQR, 4–84), mostly after surgery (54%) and in one third after medical therapy. Fistula recurrence was uncommon (11%) after closure. Patient and fistula characteristics were significantly different after the availability of biologics. In fact, anti-TNF biologics and thiopurines reduced surgery risk (HR 0.5; 0.38–0.67; HR 0.64; 0.47–0.86, respectively). The surgery rate in the biologic era tends to be lower than before (OR 0.63;0.33–1.09) while timing is similar. Closure rates are also comparable, but it was obtained more frequently after medical therapy once biologicals were available (OR 2.21; 1.13–4.29). Conclusion ECF complicating CD entail a high burden of medical and surgical resources. Closure rates are high, usually after surgery, and fistula recurrence is uncommon. A number of patients can benefit from medical therapy and achieve fistula closure.

Background It has been reported that familial aggregation occurs in 10–20% of inflammatory bowel disease (IBD) patients1. Familial IBD has been associated with disease anticipation2 and with an increased need for immunosuppressants3 and surgery4. However, most studies were performed before the widespread use of biological agents and this may impact on the need for surgery. We aimed to compare the clinical outcomes of IBD (by means of the need for biological therapy and abdominal surgery) between familial and sporadic forms of IBD in the era of biological therapies. Methods Data were extracted from the ENEIDA registry by GETECCU, a Spanish, prospectively-maintained, IBD database in which more than 80 centers are participating. Only adult patients diagnosed with IBD since 2005 and prospectively followed in the registry since diagnosis were included. Familial IBD was defined as those cases with at least one first-degree relative diagnosed with IBD. Sporadic IBD was defined as those cases with no familial relative (of any degree) with IBD. Kaplan-Meier survival curves were performed to evaluate the cumulative probabilities of remaining biologic-free and surgery-free. Log-rank test was performed to compare them between familial and sporadic IBD forms. Chi-square test was performed for the rest of variables. Results A total of 5,263 patients (2,627 Crohn’s disease [CD]; 2,636 ulcerative colitis [UC]) were included. Of them, 507 (10%) were familial cases (274 CD, 233 UC; P=0.05). The median follow-up was 38,4 and 35.5 months, respectively (P=0.086). Familial cases were younger (P=0.022) and had a higher proportion of females among UC cases (P=0.048). No differences were observed in the need for biological therapy in both CD and UC between familial and sporadic IBD. Regarding surgery, no differences were observed in the cumulative probabilities of a first intestinal resection for CD and colectomy for UC. Similar results were obtained when all the analyses were restricted to those subgroups at high-risk for surgery (i.e. CD with ileal involvement and extensive UC). Conclusion In patients diagnosed with IBD in the era of biological therapies, familial forms have the same requirements for biological agents and resectional surgery as sporadic forms. Therefore, familial aggregation does not seem to be a factor for a more aggressive disease.

[Background and Aims] To evaluate the clinical outcomes in patients with IBD after switching from Remicade® to CT-P13 in comparison with patients who maintain Remicade®., [Methods] Patients under Remicade® who were in clinical remission with standard dosage at study entry were included. The ‘switch cohort’ [SC] comprised patients who made the switch from Remicade® to CT-P13, and the ‘non-switch’ cohort [NC] patients remained under Remicade®., [Results] A total of 476 patients were included: 199 [42%] in the SC and 277 [58%] in the NC. The median follow-up was 18 months in the SC and 23 months in the NC [p < 0.01]. Twenty-four out of 277 patients relapsed in the NC; the incidence of relapse was 5% per patient-year. The cumulative incidence of relapse was 2% at 6 months and 10% at 24 months in this group. Thirty-eight out of 199 patients relapsed in the SC; the incidence rate of relapse was 14% per patient-year. The cumulative incidence of relapse was 5% at 6 months and 28% at 24 months. In the multivariate analysis, the switch to CT-P13 was associated with a higher risk of relapse (HR = 3.5, 95% confidence interval [CI] = 2–6). Thirteen percent of patients had adverse events in the NC, compared with 6% in the SC [p < 0.05]., [Conclusions] Switching from Remicade® to CT-P13 might be associated with a higher risk of clinical relapse, although this fact was not supported in our study by an increase in objective markers of inflammation. The nocebo effect might have influenced this result. Switching from Remicade® to CT-P13 was safe., This research has been funded by grants from the Instituto de Salud Carlos III [PI13/00041 and FI17/00143].

Background Three anti-TNFs (one intravenous and two subcutaneous) are licensed for the treatment of ulcerative colitis (UC). However, it is not known if the efficacy of a second anti-TNF changes on whether it is intravenous or subcutaneous; this could justify the indication of biological agents with a different mechanism of action in second line. The aim of this study was to compare the efficacy of a second subcutaneous or intravenous anti-TNF in UC. Methods Patients from the prospectively maintained ENEIDA registry treated with consecutively intravenous and subcutaneous anti-TNF, who were naïve to biological agents, were identified. Patients were classified according to the administration route of the first anti-TNF in: IVi (intravenous initially) or SCi (subcutaneous initially). Patients treated for extraintestinal manifestations or pouchitis were excluded. Clinical activity and effectiveness were defined based on Partial Mayo Score (PMS) at baseline, 14 and 52 weeks. Loss of response, dose-escalation and treatment discontinuation were also assessed. Results 372 UC patients were included (270 IVi and 102 SCi). Both cohorts were similar in clinical-epidemiological characteristics, except for a higher proportion of patients with moderate-to-severe clinical activity at the beginning of the first anti-TNF in the IVi group (82% vs. 71%; p = 0.017) and at the beginning of the second anti-TNF (62% vs. 74%; p = 0.04). Clinical response and remission rates at week 14 for the second anti-TNF were 41% and 29% in IVi vs. 47% and 25% in SCi, respectively (p = ns). At week 52, clinical response/remission rates of the second anti-TNF were 37%/32% in IVi vs. 40%/29% in SCi (p = ns). A higher response rate at 14 weeks with the second anti-TNF was detected in the SCi group (40% vs. 68%; p = 0.012) when the reason for withdrawal of the first anti-TNF was secondary loss of response. The cumulative persistence of the second anti-TNF treatment in IVi and SCi were 55% and 54% after 1 year, and 41% and 40% after 2 years, respectively (p = ns). The SCi group had lower rates of dose-escalation with the second anti-TNF than IVi (34% and 29% in SCi vs. 57% and 49% in EVi, at 12 and 24 months, respectively -p = 0.004-). Dose-escalation of the first anti-TNF and moderate-to-severe clinical activity at the beginning of the second anti-TNF were associated with a lower probability of remission with the second anti-TNF in the short- and long-term. Conclusion The efficacy of infliximab after failure/intolerance of a subcutaneous anti-TNF is similar to that of subcutaneous anti-TNFs after infliximab failure/intolerance.

ObjetivoEvaluar la evolución clínica y la utilización de recursos sanitarios en atención primaria un año después del tratamiento erradicador de Helicobacter pylori (Hp) en pacientes con úlcera péptica e infección por Hp.DiseñoEstudio retrospectivo sobre el efecto de una intervención.Ámbito del estudioCentro de atención primaria urbano y reformado.PacientesCiento dos pacientes con enfermedad ulcerosa péptica e infección por Hp.IntervenciónTratamiento erradicador de Hp.Mediciones y resultados principalesa) número de visitas totales (VT); b) visitas por dispepsia (VD); c) número de brotes ulcerosos (BU), y d) fármacos consumidos para tratamiento de la dispepsia. De los pacientes tratados un 79,4% era varón. La edad media global fue de 47,8 ± 12,4 años. Después de la intervención, disminuyeron significativamente las VT (de 8,3 a 6,6; p < 0,001), las VD (3,1 a 1,1; p < 0,00001), y los BU (de 1,2 a 0,06; p < 0,00001). El número medio de fármacos prescritos para la dispepsia por paciente disminuyó de 1,24 a 0,43 (p < 0,0001). La prescripción de ranitidina pasó de 72,7 a 13,8 días (p < 0,001) y la de omeprazol disminuyó de 35,1 a 12,2 días (p < 0,03). El ahorro total estimado por paciente fue de 26.792 pts. con valores económicos de 1998.ConclusionesEn nuestro medio el tratamiento erradicador en pacientes ulcerosos Hp (+) disminuye las necesidades de asistencia y la prescripción de medicamentos antiulcerosos. Ya durante el primer año esto supone un beneficio clínico para estos pacientes y un ahorro económico importante para la sanidad pública.ObjectivesTo evaluate the clinical evolution and the use of Primary Care health resources one year after treatment to eradicate Helicobacter pylori (Hp) infection in patients with peptic ulcers and Hp infection.DesignRetrospective study on the effect of an intervention.SettingUrban, reformed primary care centre.Patients102 patients with peptic ulcers and Hp infection.InterventionTreatment to eradicate Hp.Measurements and main resultsa) Total medical attendance; b) attendance for dyspepsia; c) number of ulcerous outbreaks; d) medicines taken to treat dyspepsia. 79.4% of the patients treated were male. Overall mean age was 47.8 ± 12.4. After the intervention, total attendance (from 8.3 to 6.6, p < 0.001), attendance for dyspepsia (from 3.1 to 1.1, p < 0.00001), and ulcerous outbreaks (from 1.2 to 0.06, p < 0.00001) all dropped sharply. The mean number of medicines prescribed for dyspepsia per patient fell from 1.24 to 0.43, p < 0.0001. Ranitidine prescription fell from 72.7 to 13.8 days (p < 0.001); and omeprazol from 35.1 to 12.2 days (p < 0.03). Estimated total saving per patient was 26792 pesetas at 1998 values.ConclusionsTreatment in primary care to eradicate Hp (+) in ulcerous patients reduced the needs of attendance and the prescription of drugs for ulcers. Just in the first year this supposed a clinical benefit for these patients and important economic savings for the public health service.

Even with the current most effective treatment regimens, a relevant proportion of patients will fail to eradicate Helicobacter pylori infection.To evaluate the role of rifabutin in the treatment of H. pylori infection.Bibliographical searches were performed in MEDLINE. Data on the efficacy of rifabutin-containing regimens on H. pylori eradication were combined and meta-analysed using the generic inverse variance method.Rifabutin shows good in vitro activity against H. pylori. Mean H. pylori rifabutin resistance rate (calculated from 11 studies including 2982 patients) was 1.3% (95% confidence interval = 0.9-1.7%). When only studies including patients naïve to H. pylori eradication treatment were considered, this figure was even lower (0.6%). On the other hand, higher values of rifabutin resistance were calculated (1.59%) when only post-treatment patients were considered. Overall, mean H. pylori eradication rate (intention-to-treat analysis) with rifabutin-containing regimens (1008 patients) was 73% (67-79%). Respective cure rates for second-line (223 patients), third-line (342 patients) and fourth/fifth-line (95 patients) rifabutin therapies were 79% (67-92%), 66% (55-77%) and 70% (60-79%) respectively. For treating H. pylori infection, almost all studies have administered rifabutin 300 mg/day; this dose seems to be more effective than 150 mg/day. The ideal length of treatment remains unclear, but 10- to 12-day regimens are generally recommended. The mean rate of adverse effects was 22% (19-25%). Myelotoxicity is the most significant, although this complication was rare. Until now, all patients have recovered of leucopenia uneventfully in a few days, and there have been no reports of infection or other adverse outcomes related to it.Rifabutin-containing rescue therapy constitutes an encouraging strategy after multiple (usually three) previous eradication failures with key antibiotics such as amoxicillin, clarithromycin, metronidazole, tetracycline and levofloxacin.

BACKGROUND A decrease in the Helicobacter pylori eradication rate after standard triple therapy has been suggested in recent years. AIM To assess the efficacy of standard triple therapy in the eradication of H. pylori through an epidemiological analysis of all published Spanish trials. A secondary aim was to review the prevalence of clarithromycin resistance in Spain. METHODS Articles on H. pylori eradication in Spain published in peer-reviewed journals were identified through MEDLINE searches. Studies that included a triple therapy consisting of any proton pump inhibitor with clarithromycin (500 mg b.d.) and amoxicillin (1 g b.d.) for up to 14 days were selected. Spanish studies evaluating the prevalence of clarithromycin resistance were also reviewed. Meta-analysis was performed using the generic inverse variance method. RESULTS The pooled eradication rates by year from Spanish studies evaluating the efficacy of the standard triple regimen revealed a relatively constant rate over the years. Overall, the analysis of the 32 studies (4727 patients) showed a mean H. pylori cure rate of 80% (95% CI = 77-82%) by intention-to-treat and 83% (81-86%) by per-protocol. When only peptic ulcer disease or 7-day regimens were considered, results were similar. Based on 13 studies (3293 patients), mean clarithromycin resistance rate was 8% (5-10%). CONCLUSION Although a decrease in the H. pylori eradication rate after triple therapy has been suggested in recent years, cure rates with this regimen did not change in Spain between 1997 and 2008. However, this by no means indicates that the efficacy of standard triple therapy in Spain is acceptable, as it has been calculated to be around only 80%. Therefore, it is evident that new strategies to improve first-line treatment are urgently needed.

Helicobacter pylori infection is the main cause of gastric mucosa-associated lymphoid tissue (MALT) lymphoma.To review several common misconceptions in the management of H. pylori-associated gastric MALT-lymphoma.Bibliographical searches were performed in MEDLINE up to June 2011.If adequate diagnostic methods are used, and if only low-grade lymphomas are considered, the prevalence of H. pylori infection is very high (almost 90%). H. pylori eradication is effective in treating approximately 80% of patients with early stage lymphoma. In H. pylori-positive gastric high-grade lymphomas, antibiotic therapy should always be prescribed, as approximately 50% of them regress after H. pylori eradication. Patients with early stage MALT lymphoma negative for H. pylori might still benefit from antibiotic treatment as the sole treatment. Complete remission of gastric MALT lymphoma after H. pylori eradication can take even12 months. PCR assay for the detection of monoclonal B cells remains positive in many cases after complete remission has been reached. Patients with a persistent clonal band should not be treated unless the lymphoma can be histologically demonstrated. Synchronous occurrence of gastric adenocarcinoma and MALT lymphoma has been repeatedly reported. In some patients in complete remission, eradication of H. pylori does not prevent later development of early gastric cancer. Gastric lymphoma recurrence occurs in some patients after both bacterial and lymphoma regression. H. pylori reinfection does not constitute a prerequisite for lymphoma recurrence.The present article states several misconceptions in the management of H. pylori-associated gastric MALT-lymphoma in clinical practice, reviews the related scientific evidence and proposes the adequate attitude in each case.

Determining the risk of rebleeding after endoscopic therapy for peptic ulcer bleeding (PUB) may be useful for establishing additional haemostatic measures in very high-risk patients.To identify predictors of rebleeding after endoscopic therapy.Bibliographic database searches were performed to identify studies assessing rebleeding after endoscopic therapy for PUB. All searches and data abstraction were performed in duplicate. A parameter was considered to be an independent predictor of rebleeding when it was detected as prognostic by multivariate analyses in ≥2 studies. Pooled odds ratios (pOR) were calculated for prognostic variables.Fourteen studies met the prespecified inclusion criteria. Pre-endoscopic predictors of rebleeding were: (i) Haemodynamic instability: significant in 9 of 13 studies evaluating the variable (pOR: 3.30, 95% CI: 2.57-4.24); (ii) Haemoglobin value: significant in 2 of 10 (pOR: 1.73, 95% CI: 1.14-2.62) and (iii) Transfusion: significant in two of six (pOR not calculable). Endoscopic predictors of rebleeding were: (i) Active bleeding: significant in 6 of 12 studies (pOR: 1.70, 95% CI: 1.31-2.22); (ii) Large ulcer size: significant in 8 of 12 studies (pOR: 2.81, 95% CI: 1.98-4.00); (iii) Posterior duodenal ulcer location: significant in four of eight studies (pOR: 3.83, 95% CI: 1.38-10.66) and (iv) High lesser gastric curvature ulcer location: significant in three of eight studies (pOR: 2.86; 95% CI: 1.69-4.86).Major predictors for rebleeding in patients receiving endoscopic therapy are haemodynamic instability, active bleeding at endoscopy, large ulcer size, ulcer location, haemoglobin value and the need for transfusion. These risk factors may be useful for guiding clinical management in patients with PUB.

Temporal changes in the incidence of cause-specific gastrointestinal (GI) complications may be one of the factors underlying changing medical practice patterns.To report temporal changes in the incidence of five major causes of specific gastrointestinal (GI) complication events.Population-based study of patients hospitalised due to GI bleeding and perforation from 1996 to 2005 in Spain. We report crude rates, and estimate regression coefficients of temporal trends, severity and recorded drug use for five frequent GI events. GI hospitalisation charts were validated by independent review of large random samples.The incidence per 100 000 person-years of hospitalisations due to upper GI ulcer bleeding and perforation decreased over time [from 54.6 and 3.9 in 1996 (R² = 0.944) to 25.8 and 2.9 in 2005 (R² = 0.410) respectively]. On the contrary, the incidence per 100 000 person-years of colonic diverticular and angiodysplasia bleeding increased over time [3.3 and 0.9 in 1996 (R² = 0.443) and 8.0 and 2.6 in 2005 (R² = 0.715) respectively]. A small increasing trend was observed for the incidence per 100 000 person-years of intestinal perforations (from 1.5 to 2.3 events). Based on data extracted from the validation process, recent recorded drug intake showed an increased frequency of anticoagulants with colonic diverticular and angiodysplasia bleeding, whereas NSAID and low-dose aspirin use were more prevalent in peptic ulcer bleeding and colonic diverticular bleeding respectively.From 1996 to 2005, hospitalisations due to peptic ulcer bleeding and perforation have decreased significantly, whereas the number of cases of colonic diverticular and angiodysplasia bleeding have increased.

Endoscopic therapy reduces rebleeding rate, need for surgery, and mortality in patients with bleeding peptic ulcers. Injection of epinephrine is the most popular therapeutic method. Guidelines disagree on the need for a second haemostatic procedure immediately after epinephrine.The objective of this review was to determine whether the addition of a second procedure improves efficacy or patient outcomes or both after epinephrine injection in adults with high risk bleeding ulcers.We searched the Cochrane Central Register of Controlled Trials - CENTRAL (which includes the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group Trials Register) (The Cochrane Library Issue 1, 2006), MEDLINE (1966 to February 2006), EMBASE (1980 to February 2006) and reference lists of articles. We also contacted experts in the field.Randomised studies comparing endoscopic treatment: epinephrine alone versus epinephrine associated with a second haemostatic method in adults with haemorrhage from peptic ulcer disease with major stigmata of bleeding as defined by the Forrest classification. Bleeding must have been confirmed by endoscopy.Two authors independently assessed trial quality and extracted data.Seventeen studies including 1763 people were included. Adding a second procedure reduced further bleeding rate from 18.8% to 10.4%; Peto Odds Ratio 0.51; 95% confidence interval (CI) 0.39 to 0.66, and emergency surgery from 10.8% to 7.1%; OR 0.63; 95% CI 0.45 to 0.89. Mortality fell from 5% to 2.5% OR 0.50; 95% CI 0.30 to 0.82. Subanalysis showed that the risk of further bleeding decreased regardless of which second procedure was applied. In addition, the risk was reduced in all subgroups.Additional endoscopic treatment after epinephrine injection reduces further bleeding, the need for surgery and mortality in patients with bleeding peptic ulcer.

To evaluate the accuracy of several methods aimed to detect Helicobacter pylori stool antigens in patients with upper gastrointestinal bleeding.Thirty-four patients with upper gastrointestinal bleeding because of peptic ulcer were included. The first stool sample during hospitalization was collected, and stool antigens were determined with: polyclonal enzyme-linked immunosorbent assay (Premier-Platinum-HpSA); monoclonal enzyme-linked immunosorbent assay (Amplified-IDEIA-HpStAR); and rapid monoclonal immunochromatographic test (ImmunoCard-STAT HpSA). A patient was considered infected when H. pylori was diagnosed with invasive tests (rapid urease test or histology) or with (13)C-urea breath test. When all tests were negative, a new breath test was repeated after stopping proton pump inhibitors.All patients were infected and, therefore, only sensitivity of the tests could be calculated: polyclonal enzyme-linked immunosorbent assay (74%), monoclonal enzyme-linked immunosorbent assay (94%), and rapid monoclonal immunochromatographic test (60%; concordance between the two observers was high, kappa = 0.9). Neither the presence of maelena nor the delay in obtaining stool samples explained false negatives.Neither the polyclonal enzyme-linked immunosorbent assay stool antigen test nor the rapid immunochromatographic stool antigen test can be recommended to diagnose H. pylori infection in patients with upper gastrointestinal bleeding. However, the monoclonal enzyme-linked immunosorbent assay stool antigen test is highly sensitive for detecting the infection in patients with this complication, although more studies are necessary to evaluate the specificity of the method.

It is not known whether certain proton-pump inhibitors are more efficacious than others when used in triple therapy for Helicobacter pylori eradication.To compare the efficacy of different proton-pump inhibitors in triple therapy by performing a meta-analysis.A MEDLINE search was performed. Abstracts of the European Helicobacter pylori Study Group and the American Gastroenterological Association congresses from 1996 to 2002 were also examined. Randomized studies with at least two branches of triple therapy that differed only in terms of type of proton-pump inhibitor were included in a meta-analysis using Review Manager 4.1.Fourteen studies were included. Intention-to-treat cure rates were similar for omeprazole and lansoprazole: 74.7% vs. 76%, odds ratio (OR) 0.91 [95% confidence interval (CI) 0.69-1.21] in a total of 1085 patients; for omeprazole and rabeprazole: 77.9% vs. 81.2%, OR 0.81 (95% CI 0.58-1.15) in a total of 825 patients; for omeprazole and esomeprazole: 87.7% vs. 89%, OR 0.89 (95% CI 0.58-1.35) in 833 patients; and for lansoprazole and rabeprazole: 81% vs. 85.7%, OR 0.77 (95% CI 0.48-1.22) in 550 patients.The efficacy of various proton-pump inhibitors seems to be similar when used for H. pylori eradication in standard triple therapy.

Triple therapy (proton pump inhibitor, clarithromycin and amoxicillin or an imidazole) is the first-line treatment for Helicobacter pylori infection. However, the effectiveness of triple therapy is decreasing due to the increase in antibiotic resistance. Quadruple therapy (proton pump inhibitor, tetracycline, metronidazole and a bismuth salt) is a very effective regimen even in areas of high prevalence of antibiotic resistance, and may be an alternative first-line treatment.To compare triple vs. quadruple therapy for the first-line treatment of H. pylori infection.An extensive literature search was performed to identify randomized trials comparing triple vs. quadruple therapy. Selected trials were included in a meta-analysis using Review Manager 4.1.Four studies met the inclusion criteria. Eradication rates with quadruple therapy were slightly higher in both the intention-to-treat (81% vs. 78%; odds ratio, 0.83; 95% confidence interval, 0.61-1.14) and per protocol (88% vs. 85%; odds ratio, 0.81; 95% confidence interval, 0.55-1.20) analysis, although the differences were not statistically significant. Nor were there significant differences in compliance or adverse effects between the therapies.Triple and quadruple therapies seem to be roughly equivalent in terms of effectiveness, compliance and side-effects profile when administered as first-line treatment for H. pylori infection.

Helicobacter pylori infection may lead to peptic ulcer disease, and causes significant morbidity in patients with cirrhosis. The measurement of H. pylori antigens in human stools has been proposed as a valuable, non-invasive, diagnostic tool. A number of tests have recently been commercialized. However, very few data are available on their reliability in patients with cirrhosis.To evaluate the usefulness of three new tests--HpSA (Meridian Diagnostics Inc., Cincinnati, OH, USA), Simple H. pyl (OPERON S.A., Zaragoza, Spain) and FemtoLab H. pylori (Connex, Martinsried, Germany)--in the diagnosis of H. pylori infection in cirrhotic patients.H. pylori infection was determined in 79 cirrhotic patients (48 men, 31 women; age range, 29-82 years; mean, 62 +/- 11 years) by concordance of histology and urea breath test. The sensitivity, specificity and positive and negative predictive values of each stool test were calculated.According to the reference method, the sensitivities of HpSA, Simple H. pyl and FemtoLab H. pylori immunoassays were 76%, 87% and 78%, respectively, and their specificities were 93%, 62% and 79%, respectively.Faecal tests are non-invasive and easy-to-perform tools for the diagnosis of H. pylori infection. However, their sensitivity and specificity seem to be non-optimal in patients with cirrhosis.

To perform a systematic review of the efficacy of rabeprazole-based therapies in Helicobacter pylori eradication, and to conduct a meta-analysis comparing the efficacy of rabeprazole and other proton pump inhibitors when co-prescribed with antibiotics.Studies evaluating rabeprazole plus antibiotics were considered. Only randomized trials comparing rabeprazole and other proton pump inhibitors with antibiotics, and differing only in the proton pump inhibitor, were included in the meta-analysis. Electronic and manual bibliographic searches were conducted. The percentage (weighted mean) of successful eradication was calculated. Meta-analysis was performed by combining the odds ratios (OR) of the individual studies.The eradication rates were as follows: 14-day rabeprazole-amoxicillin, 73%; rabeprazole-amoxicillin-clarithromycin for 3, 5, 7 and 10 days, 44%, 72%, 78% and 75%, respectively; low-dose rabeprazole (20 mg/day), amoxicillin and clarithromycin for 7 days, 81%; high-dose rabeprazole (40 mg/day), amoxicillin and clarithromycin for 7 days, 75%; 7-day rabeprazole-clarithromycin-nitroimidazole, 85%. Twelve comparative studies were included in the meta-analysis. The eradication rate with rabeprazole plus antibiotics was 79%; it was 77% with other proton pump inhibitors (OR = 1.15; 95% confidence interval, 0.93-1.42). Sub-analysis comparing rabeprazole at low doses (10 mg b.d.) with other proton pump inhibitors at standard doses (omeprazole 20 mg b.d. or lansoprazole 30 mg b.d.) showed no differences.Rabeprazole achieves similar H. pylori eradication rates to omeprazole and lansoprazole when co-prescribed with antibiotics. Low doses of rabeprazole (10 mg b.d.), when administered with two antibiotics, may be sufficient to eradicate H. pylori infection.

Helicobacter pylori-associated peptic ulcer is a frequent complication in cirrhotic patients and its morbidity rate is high. In spite of this, diagnostic methods for H. pylori infection have not been fully evaluated in these patients.To evaluate H. pylori diagnostic methods in patients with liver cirrhosis.One hundred and one cirrhotic patients were included in the study. Three antral and two corpus biopsies were obtained for rapid urease test of the antral mucosa, and Giemsa stain and immunohistochemistry were performed for both the corpus and antrum. Serology, 13C-urea breath test and faecal H. pylori antigen determination were also carried out.Sixty-two patients were positive and 35 were negative for H. pylori infection; four were indeterminate. The sensitivity and specificity were 90.4% and 100%, respectively, for antral histology, 100% and 100% for gastric body histology, 90.4% and 100% for antral immunohistochemistry, 96.2% and 96.7% for body immunochemistry, 85.7% and 97% for rapid urease test, 83.6% and 55.9% for serology, 96.4% and 97.1% for 13C-urea breath test and 75.4% and 94.1% for faecal antigen.The most reliable tests for H. pylori infection in cirrhotic patients were the 13C-urea breath test and gastric body histology.

Seven-day triple therapy including omeprazole, clarithromycin and amoxicillin has become the treatment of choice for Helicobacter pylori infection. However, 7 days of classical quadruple therapy combining omeprazole, tetracycline, metronidazole and bismuth may be an alternative to triple therapy.To compare triple vs. quadruple therapy for H.pylori eradication.Three hundred and thirty-nine patients with peptic ulcer and H. pylori infection were included in the study. Patients were randomized to receive omeprazole, 20 mg, amoxicillin, 1 g, and clarithromycin, 500 mg, all b.d., or omeprazole, 20 mg b.d., tetracycline chloride, 500 mg, metronidazole, 500 mg, and bismuth subcitrate, 120 mg, all t.d.s. Cure was defined as a negative urea breath test at least 2 months after treatment.Per protocol and intention-to-treat cure rates were 86%[95% confidence interval (CI), 80-91%] and 77% (95% CI, 70-83%) for triple therapy, and 89% (95% CI, 82-93%) and 83% (95% CI, 76-88%) for quadruple therapy. No significant differences between the groups were found in the cure rates, compliance or side-effects.One-week triple and quadruple therapy show similar results when used as first-line eradication treatment.